New incident report
Incident Report Number: 2022-1214
Registrant Reference Number: M-800905-01-1
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: Suite 200, 160 Quarry Park Boulevard SE
City: CALGARY
Prov / State: AB
Country: Canada
Postal Code: T2C 3G3
Scientific Study
PMRA Registration No. 19204 PMRA Submission No. EPA Registration No.
Product Name: Phenmedipham TC
Unknown
Unknown
Title Phenmedipham: Fish Short-Term Reproduction Assay with the FatheadMinnow (Pimephales promelas)
Date 31-JAN-22
No
New health or environmental hazard
Statistical analysis concluded that there was a treatment-related effect observed on fecundity, in terms of the cumulative number of eggs produced and the number of eggs produced per female per reproductive day, at the 0.176 mg phenmedipham+MHPC/L (0.0956 mg phenmedipham/L) treatment level compared to the control. This appears to be lower than the current chronic 28-day fish LOEC for fry survival (0.181 mg phenmedipham+MHPC/L), thus would meet the criteria for adverse effects reporting [Matlock, et. al. 2014; Early Life Stage Toxicity of Phenmedipham to the Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions]. However, this study is not considered appropriate for assessing chronic risk to fish for 2 reasons. First, this study is an endocrine screening study. Second, there are a limited number of test concentrations employed and a specific dose-spacing factor and these constraints do not provide for the type of dose-response analysis that lends to a robust risk assessment endpoint.
No
The fish short-term reproduction assay was conducted to meet endocrine testing requirements for active ingredients in the European Union. The study met reportability criteria under Canadian adverse effects reporting guidelines.